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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035971
Receipt No. R000040953
Scientific Title prospective study of mild cognitive impairment and dementia in Kurashiki.
Date of disclosure of the study information 2019/05/01
Last modified on 2019/02/21

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Basic information
Public title prospective study of mild cognitive impairment and dementia in Kurashiki.
Acronym prospective study of mild cognitive impairment and dementia in Kurashiki.
Scientific Title prospective study of mild cognitive impairment and dementia in Kurashiki.
Scientific Title:Acronym prospective study of mild cognitive impairment and dementia in Kurashiki.
Region
Japan

Condition
Condition dementia,Mild cognitive impairment
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishiment of clinical biomarker for dementia.
Basic objectives2 Others
Basic objectives -Others Clinical information to be collected (patient basic information, diagnosis, comprehensive function, neuropsychological data, physical function, brain imaging, blood, cerebrospinal fluid), efficiently register, and data accumulation to create a system that can utilize data.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes neuropsychological data(MMSE, HDS-R, FAB)
Key secondary outcomes EEG, MRI, SPECT

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients over the age of 20 who have been diagnosed with dementia or MCI.
Key exclusion criteria no
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Mihara
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL 0864621111
Email mihara@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Kutoku
Organization Kawasaki Medical School
Division name neurology
Zip code
Address 577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL 0864621111
Homepage URL
Email kutoku@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective cohot investigating effective biomarker for dementia progression,using annual clinical data(neuropsychological examination, EEG, MRI and SPECT etc.)

Management information
Registered date
2019 Year 02 Month 21 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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